[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Notices]
[Pages 831-832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]


Guidance for Industry on Qualification Process for Drug 
Development Tools; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Qualification 
Process for Drug Development Tools.'' This guidance describes the 
qualification process for drug development tools intended for potential 
use, over time, in multiple drug development programs. The guidance 
provides a framework for interactions between FDA and sponsors to 
support work towards qualification of an identified drug development 
tool and creates a mechanism for formal review of data to qualify the 
tool and ensure that the evaluation is comprehensive and reliable.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Shaniece Bowens, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 4555, Silver Spring, MD 20993-0002, 301-
796-2600.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Qualification Process for Drug Development Tools.'' The 
guidance describes the qualification process for drug development tools 
(DDTs) intended for potential use, over time, in multiple drug 
development programs.
    In March 2006, FDA issued the ``Critical Path Opportunities Report 
and List,'' in which FDA described six key areas along the critical 
path to improved therapies and listed specific opportunities for 
advancement within these topic areas. The report noted that a new 
product development toolkit containing new scientific and technical 
methods was needed to improve the efficiency of drug development. Too 
often, attention to a needed DDT is delayed until the time when the 
registration study protocols are under development and the available 
DDTs are inadequate. Innovative and improved DDTs can help streamline 
the drug development process, improve the chances for clinical trial 
success, and yield more information about a treatment and/or disease. 
DDTs include, but are not limited to, biomarkers and patient reported 
outcome instruments. This guidance describes a formal

[[Page 832]]

process that FDA will use in working with sponsors of these tools to 
guide them as they refine the tools and rigorously evaluate them for 
use in the regulatory process.
    A draft version of this guidance was issued in the Federal Register 
of October 25, 2010 (75 FR 65495). FDA received a number of comments, 
most of which focused on clarifications and further illustration of the 
qualification process. FDA reviewed all received comments carefully 
during the finalization process of the guidance; the Agency has made 
some clarifying changes in the final version of the guidance. 
Specifically, FDA provided general guidance on the qualification 
process, samples of what should be included in a qualification package, 
and examples of drug development tools. A new DDT, Animal Models under 
the Animal Rule, has been included and discussed in the final DDT 
guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on the qualification process for drug 
development tools. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such an approach satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance contains an information collection that is subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The information collection 
has been approved under the OMB control numbers 0910-0001 and 0910-
0014. The information requested in the guidance is currently submitted 
to FDA to support medical product effectiveness (see 21 CFR 312.30, 21 
CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00028 Filed 1-6-14; 8:45 am]
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